Ignite Creation Date:
2025-12-24 @ 9:30 PM
Ignite Modification Date:
2025-12-25 @ 7:16 PM
Study NCT ID:
NCT01514032
Status:
UNKNOWN
Last Update Posted:
2012-01-20
First Post:
2012-01-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Extracorporal Shockwave Lithotripsy Versus Retrograde Intrarenal Surgery for the Treatment of Kidney Stones
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007669', 'term': 'Kidney Calculi'}], 'ancestors': [{'id': 'D053040', 'term': 'Nephrolithiasis'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052878', 'term': 'Urolithiasis'}, {'id': 'D014545', 'term': 'Urinary Calculi'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D002137', 'term': 'Calculi'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 230}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2011-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-01', 'completionDateStruct': {'date': '2014-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2012-01-19', 'studyFirstSubmitDate': '2012-01-16', 'studyFirstSubmitQcDate': '2012-01-19', 'lastUpdatePostDateStruct': {'date': '2012-01-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-01-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'stonefree-rates 3month after therapy', 'timeFrame': '3 month'}]}, 'conditionsModule': {'conditions': ['Kidney Stones']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to compare two established modalities for the treatment of kidneystones: ESWL (extracorporal shockwave-lithotripsy) vs. URS (uretero-reno-scopy with stone-extraction). Comparison of the stone-free rates 3month postoperative.\n\n* Trial with surgical intervention'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria: - kidneystones requiring treatment up to an maximal size of 15mm (singular or multiple kidneystones with at least one stone with min. 5mm of size)\n\n* male and female patients between 18 and 99 years\n* informed consent signed by patient after explanation of the both treatment-modalities\n\nExclusion criteria: - age \\< 18 or \\> 99\n\n* pregnancy\n* breastfeeding mother\n* disorders of blood clotting\n* kidneystones \\> 15mm\n* aneurysms of the aorta or renal artery\n* severe skeletal deformations which hamper one of the treatment modalities\n* synchronous stones of the ipsilateral ureter\n* stones which can not visualized which X-ray or sonography'}, 'identificationModule': {'nctId': 'NCT01514032', 'briefTitle': 'Extracorporal Shockwave Lithotripsy Versus Retrograde Intrarenal Surgery for the Treatment of Kidney Stones', 'organization': {'class': 'OTHER', 'fullName': 'University of Zurich'}, 'officialTitle': 'TOP-Stone: Treatment of Patients With Small Kidney Stones - Randomized Head-to-head Trial Comparing Extracorporal Shockwave Lithotripsy With Retrograde Intrarenal Surgery', 'orgStudyIdInfo': {'id': 'TOP-Stone'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Extracorporal shockwave lithotripsy', 'interventionNames': ['Procedure: Extracorporal shockwave lithotripsy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Retrograde intrarenal surgery', 'interventionNames': ['Procedure: Retrograde intrarenal surgery']}], 'interventions': [{'name': 'Extracorporal shockwave lithotripsy', 'type': 'PROCEDURE', 'description': 'Extracorporal shockwave lithotripsy', 'armGroupLabels': ['Extracorporal shockwave lithotripsy']}, {'name': 'Retrograde intrarenal surgery', 'type': 'PROCEDURE', 'description': 'Retrograde intrarenal surgery', 'armGroupLabels': ['Retrograde intrarenal surgery']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Zurich', 'status': 'RECRUITING', 'country': 'Switzerland', 'facility': 'University Hospital Zurich, Urology', 'geoPoint': {'lat': 47.36667, 'lon': 8.55}}], 'centralContacts': [{'name': 'Damian Weber, MD', 'role': 'CONTACT', 'email': 'damian.weber@usz.ch', 'phone': '+41 44 2555407'}, {'name': 'Michael Muentener, MD', 'role': 'CONTACT', 'email': 'michael.muentener@usz.ch', 'phone': '+41 44 2555403'}], 'overallOfficials': [{'name': '01 Studienregister MasterAdmins', 'role': 'STUDY_DIRECTOR', 'affiliation': 'UniversitaetsSpital Zuerich'}, {'name': 'Michael Muentener, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital Zurich, Division of urology'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Zurich', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}